VP, Medicine Development Leader - Specialty Product Development

SHPE Houston; Collegeville (PA); Hybrid; USD 242,000 - 404,000; Full time

Job summary

GSK seeks a VP Medicine Development Leader to strategically direct global medicine development from PoC to initial approvals in major markets. You will establish and lead the Medicine Development Team (MDT), coordinating R&D, Manufacturing, Medical and Commercial functions to deliver accelerated, high-impact development plans.

The role requires strong cross-functional leadership, strategic decision-making, and demonstrated expertise in lifecycle management, regulatory planning, and budget

Qualifications

• Advanced degree including MD, PhD, PharmD, MBA, MS
• Drug development expertise in the global pharmaceutical/biotechnology industry
• Filing experience with BLA/NDA/MAA submissions as a core responsibility
• Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing, Medical and Commercial
• Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
• Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
• Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
• Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
• Experience building budgets and leading the strategic and budget planning process
• Experience in the healthcare environment, and access in all major markets

Responsibilities

• Acting as a single point of accountability in GSK for all aspects of a medicine being developed globally, from clinical PoC to Approval in the first major market(s)
• Working closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
• Post-approval, provides key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
• Works with the functional line Heads supporting RIIRU to select MDT members and leads this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
• Partners with the Pipeline Project Manager (PPM), energizes and motivates the MDT to drive a high performing team and <b>operational delivery of the project, including </b>setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
• Partners with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
• Leads the cross-functional MDT to:
• -Establish a compelling vision for the medicine and MP which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK's strategy into asset strategy and actionable plans for multiple areas or functions
• -Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product's life cycle
• -Prioritize and maximize the asset's development options including developing multiple indications
• -Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.
• -Make clear evidence-based go / no go / accelerate decisions and identify clear inflection points, based on whether the results fulfil the strategy set out for the medicine
• -Ensure excellence in execution of all governance processes, including MDT members, e.g., the Clinical Development Lead (CDL) partnering with other matrix Leads, such as the Global Regulatory Lead (GRL), the GML, etc. on oversight of clinical studies, patient safety & pharmacovigilance, scientific engagement and promotional practices
• -Enhance patient focus by incorporating the voice of the patient into development plans
• -Increase visibility amongst the external communities (physicians, regulators, patients, payers) to bring medical solutions to patients with unmet medical needs, thereby enhancing GSK's reputation and showcasing our ambition for patients

Skills

Communication

Cross-Functional Leadership

Drug Development

Project Development

Project Implementations

Project Leadership

Scientific Research

Education

Advanced degree including MD, PhD, PharmD, MBA, MS

Job description

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

As VP Medicine Development Leader (MDL), you will strategically lead the optimal global development of a medicine at an asset level, acting as the single point of accountability for the medicine from clinical Proof of Concept (PoC) to Approval in the first major market(s).

By working with the various stakeholders across GSK's Medicine Development matrix (R&D, Manufacturing, Commercial, etc.), you will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. You will create and lead the matrixed Medicine Development Team (MDT), which is responsible for representing the various disciplines required to optimally deliver the development of the medicine including Clinical Development, Medical, Commercial and Manufacturing, amongst others.

Accountability and key responsibilities include but are not limited to:

• Acting as a single point of accountability in GSK for all aspects of a medicine being developed globally, from clinical PoC to Approval in the first major market(s)
• Working closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
• Post-approval, provides key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
• Works with the functional line Heads supporting RIIRU to select MDT members and leads this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
• Partners with the Pipeline Project Manager (PPM), energizes and motivates the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
• Partners with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
• Leads the cross-functional MDT to:
  • Establish a compelling vision for the medicine and MP which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK's strategy into asset strategy and actionable plans for multiple areas or functions
  • Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product's life cycle
  • Prioritize and maximize the asset's development options including developing multiple indications
  • Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.
  • Make clear evidence-based go / no go / accelerate decisions and identify clear inflection points, based on whether the results fulfil the strategy set out for the medicine
  • Ensure excellence in execution of all governance processes, including MDT members, e.g., the Clinical Development Lead (CDL) partnering with other matrix Leads, such as the Global Regulatory Lead (GRL), the GML, etc. on oversight of clinical studies, patient safety & pharmacovigilance, scientific engagement and promotional practices
  • Enhance patient focus by incorporating the voice of the patient into development plans
  • Increase visibility amongst the external communities (physicians, regulators, patients, payers) to bring medical solutions to patients with unmet medical needs, thereby enhancing GSK's reputation and showcasing our ambition for patients
• Serves as the asset's single point of contact and spokesperson to Senior Management, senior boards, other relevant internal governance committees and external Advisory Committees, as needed, e.g., Chief Scientific Officer, TA Head, Chief Medical Officer, TA Development Review Board and Portfolio Investment Board
• Delivers and manages the asset resourcing plan (people & finances), including serving as the single point for accountability for managing the asset budget to the agreed variance, working closely with the PPM and Finance Partner to do so

This position is offered as a hybrid position with a required on-site presence at least two days per week at one of GSKs US (Waltham, MA or Upper Providence, PA) or UK (GSK HQ or Stevenage/Cambridge) sites.

Basic Qualifications:

• Advanced degree including MD, PhD, PharmD, MBA, MS
• Drug development expertise in the global pharmaceutical/biotechnology industry
• Filing experience with BLA/NDA/MAA submissions as a core responsibility
• Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing, Medical and Commercial
• Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
• Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
• Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
• Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
• Experience building budgets and leading the strategic and budget planning process
• Experience in the healthcare environment, and access in all major markets

Preferred Qualifications:

• Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills
• Strong matrix leadership and motivational skills
• Ability to work collaboratively and successfully across functions - Research, Commercial, Regulatory, Global Medicine Supply, Legal, regions etc.

Skills

Communication, Cross-Functional Leadership, Drug Development, Project Development, Project Implementations, Project Leadership, Scientific Research

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $242,250 to $403,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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